510(k) Report

Devices descending from K890939

793 later devices reach Dupont Distal Humeral Nail through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+4K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+4K254162KLS Martin Ixos SystemKLS Martin L.P.20260—
+4K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+4K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+4K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+4K252356The Acumed Wrist Fixation System - 2.4mm ScrewsAcumed, LLC20250—
+4K252061Distal Xtremities SystemTriMed, Inc.20250—
+4K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+4K243368Montblanc Plate SystemMedifield Medical Co., Ltd.20250—
+4K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+4K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+4K250948TriMed Fusion Cup SystemTriMed, Inc.20250—
+4K243987TriMed Elbow and Forearm SystemTriMed, Inc.20251—
+4K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+4K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+4K243740Versalock Upper Limb Plating SystemGM Dos Reis Industria e Comercio Ltda.20251—
+4K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+4K242998GMReis Ankle Plating SystemGM Dos Reis Industria e Comercio Ltda.20241—
+4K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+4K242079Arthrex Elbow Fracture Plating SystemArthrex, Inc.20240—
+4K240175Tigon Medical Fractures, Instability, and Reconstruction (FIRE)Tigon Medical20240—
+4K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+4K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+4K242055Freefix Forearm Plating SystemSkeletal Dynamics, Inc.20240—
+4K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+4K230546SignexOsteonic Co., Ltd.20242—
+4K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+4K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+4K233017TM Plating SystemTyber Medical, LLC20231—
+4K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+4K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+4K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+4K223118OIC Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20231—
+4K221412ARIX Rib SystemJeil Medical Corporation20221—
+4K222244Arthrex 3.5 mm Locking Compression PlatesArthrex, Inc.20221—
+4K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+4K213837Arthrx Fracture PlatesArthrex, Inc.20220—
+4K220244DVR® Crosslock Wrist Spanning Plate (131849181)Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech20220—
+4K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+4K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+4K202803Activmotion S DTONewclip Technics20210—
+4K213214Xpert WristNewclip Technics20210—
+4K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+4K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation20210—
+4K211592Avanti Orthopaedics Ulnar Shortening SystemAvanti Orthopaedics, Inc.20211—
+4K203405EVOS Large Fragment Plating SystemSmith & Nephew, Inc.20213—
+4K201918EVOS Large Fragment Plating SystemSmith & Nephew, Inc.202044
+4K202589APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS…Medartis AG202061
+4K201235Arthrex MaxForce MTP Compression Plates and ScrewsArthrex, Inc.20200—
+4K193639APTUS® Foot 2.8-3.5 SystemMedartis AG20209—
+4K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+4K191972ARIX Wrist SystemJeil Medical Corporation20190—
+4K190166TriMed Nitinol Staple SystemTriMed, Inc.20190—
+4K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+4K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+4K171808TDM Plate and Screw SystemTdm Co., Ltd.20186—
+4K173746Activmotion RangeNewclip Technics20181—
+4K173293EVOS Small Fragment Upper Extremity PlatesSmith & Nephew, Inc.201812—
+4K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+4K170972Apex Tibial Nailing SystemOrthoxel20171—
+4K172886Breakaway Screw SystemParagon 2820174—
+4K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+4K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+4K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+4K170780ARIX Foot System (2.3/2.8)Jeil Medical Corporation20174—
+4K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC2017151
+4K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+4K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+4K170843Alians Fragment SpecificNewclip Technics20171—
+4K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+4K170457EVOS Small Fragment Lower Extremity PlatesSmith & Nephew, Inc.2017131
+4K161327Syntec Humeral Nail SystemSyntec Scientific Corporation20173—
+4K170887EVOS Small Fragment Plating SystemSmith & Nephew, Inc.201713—
+4K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+4K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+4K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+4K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+4K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+4K162078EVOS Small Fragment Plating SystemSmith & Nephew, Inc.2016261
+4K161665VLP Wrist Fracture SystemSmith & Nephew, Inc.201610—
+4K161292Distal Radius Plating SystemMiami Device Solutions, LLC20164—
+4K161058Cannulated ScrewMiami Device Solutions, LLC20161—
+4K161539Arthrosurface Bone ScrewsArthrosurface, Inc.20162—
+4K160633G3(TM) Active Plate (R) Small Fragment SystemGenesis Fracture Care, Inc.20160—
+4K153395OS2-C Compression StapleIn2bones Sas20167—
+4K151735TriMed Humeral Supracondylar Fixation SystemTriMed, Inc.20160—
+4K152145OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20151—
+4K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+4K151456Small Bone Nail ImplantVilex IN Tennessee, Inc.20150—
+4K151732Arthrex Fracture PlatesArthrex, Inc.201521—
+4K150889Suture Wires and Wire LoopsZimmer, Inc.20152—
+4K150626Rush Medullary PinsZimmer, Inc.20150—
+4K150456Arthrex Plates, Screws, and StaplesArthrex, Inc.20156—
+4K143402Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC20151—
+4K142938G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20143—
+4K141735Arthrex Ankle Fusion Plating SystemArthrex, Inc.2014381
+4K141241Matrixrib Endo Thoracoscopic Rib Plating SystemSynthes (USA) Products, LLC20145—
+4K140431Pediloc Fragment SystemOrthoPediatrics Corp.20141—
+4K141430Variax Distal Radius Plating SystemStryker Leibinger GmbH & Co KG201412—